The Difference of Angle of Femoral Component Rotation in TKA With Gap Balance and Measured Resection Technique

Not Applicable

• Conditions: Osteoarthritis, Knee
• Interventions: Procedure: the measured resection type of total knee arthroplasty; Procedure: the gap balance type of total knee arthroplasty

• Registration Number: NCT03358381
• Lead Sponsor: Peking University People's Hospital

Brief Summary

Gap balance type and measured resection type total knee arthroplasty (TKA) have different influence on the rotation of femoral component.In this study, the rotation of patients received different type of TKA will be estimated and analysed through preoperation and postoperation knee joint CT scan.

Detailed Description

This is a multicenter, double-blined, randomized controled clinical trial. 98 patients from 2 clinical center will be recruited with primary knee osteoarthritis, undergoing a primary TKA. The patients will be randomly divided into two groups , the measured resection group and the gap balance group.And the gap balance technique in this study will be achieved with a ligament tensor used during TKA. Femoral component rotation will be assessed from the preoperative and postoperative CT scans.

Study Timeline

• Status Verified: 2017-11
• Study First Submitted: 2017-11-25
• Study First Submitted QC: 2017-11-26
• Last Update Submitted: 2017-11-26
• Study First Posted: 2017-11-30
• Last Update Posted: 2017-11-30
• Study Start: 2018-01-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Severe primary osteoarthritis patients over 65 years old No obvious surgical contraindications

Exclusion Criteria

• There are surgical contraindications Varus or valgus alignment exceeds 20 degrees

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
measured resection group	the measured resection type of total knee arthroplasty	The type of total knee arthroplasty will be the measured resection.The measured resection type of total knee arthroplasty will be performed.
gap balance group	the gap balance type of total knee arthroplasty	The type of total knee arthroplasty will be the balance gap.The gap balance type of total knee arthroplasty will be performed.

Primary Outcome Measures

Name	Time	Method
femoral component rotation	6 weeks after the surgery	The change of femoral component will be assessed through preoperation as well as postoperation CT scan for knee joint.